Associate Director, Technical Operations Quality Control
Ladders · United States · 3 days ago
RemoteRemoteOTHR$150k–$195k/yrFull-time
Responsibilities
- Lead Quality Control (QC) for drug substance and product manufacturing
- Manage specification development and batch release at Contract Manufacturing Organizations (CMOs)
- Ensure compliance of products with regulations through technical support
- Oversee stability programs including study design and report approval
- Collaborate with teams on method transfers and regulatory submissions
- Support comparability assessments for process changes in manufacturing
- Guide external vendors during investigations of deviations and Out-of-Tolerance (OOS) results
Qualifications
- Bachelor's degree in Chemistry, Biochemistry, or related Life Sciences discipline; Master's preferred
- Minimum 8 years' experience in analytical operations or quality control of biologics; late-stage drug development preferred
- Strong understanding of FDA, ICH, and EU regulatory standards
- Experience with analytical methods: HPLC, GC, MS, NMR, IR, UV
- Knowledge of Good Manufacturing Practices (GMP) and regulatory affairs in the lifecycle of drug development
Benefits
- Premium health offerings for employees and dependents
- Financial and retirement plans with employer matching
- Generous paid time off and wellness programs
- Employee support and life insurance benefits